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Appearance
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White crystalline powder
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|
Assay (by HPLC; on dried basis)
|
98.0-102.0%
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|
Solubility
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Very slightly soluble in water, freely soluble in alcohol and methanol
|
|
Identification
|
-
|
|
By Infrared Absorption
|
Passes test
|
|
Melting range
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96 -99°C
|
|
Identification (by TLC)
|
Passes test
|
|
Identification ‘B’
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Passes IP test
|
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Appearance of solution
|
Passes test
|
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Colour of solution
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Passes test
|
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Acidity
|
Passes test
|
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Sulphated ash
|
Max 0.1%
|
|
Related substance (by HPLC)
|
-
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Impurity A
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Max 0.5%
|
|
Unspecified impurities
|
Max 0.5%
|
|
Total impurities
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Max 1.0%
|
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Chlorides
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Max 0.05%
|
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Sulphates
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Passes test
|
|
Loss on drying (5 hrs.over silica gel)
|
Max 0.5%
|